| CTRI Number |
CTRI/2016/03/006774 [Registered on: 30/03/2016] Trial Registered Retrospectively |
| Last Modified On: |
26/03/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Food Supplementation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ideal food for severely malnourished HIV children |
|
Scientific Title of Study
|
Evaluating the effect of nutritional supplementation combined with counselling on nutritional recovery in immuno-compromised children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamta Manglani |
| Designation |
Professor and Head |
| Affiliation |
Lokmanya Tilak Municipal General Hospital and Medical College |
| Address |
Pediatric Centre of Excellence LTMGH and LTMMC Sion Mumbai India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9821322071 |
| Fax |
|
| Email |
fmpcoe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohini Sekhar |
| Designation |
Research Officer |
| Affiliation |
Lokmanya Tilak Municipal General Hospital and Medical College |
| Address |
Pediatric Centre of Excellence LTMGH amd LTMMC Sion Mumbai India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7738904325 |
| Fax |
|
| Email |
rohinisekhar60@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohini Sekhar |
| Designation |
Research Officer |
| Affiliation |
Lokmanya Tilak Municipal General Hospital and Medical College |
| Address |
Pediatric Centre of Excellence LTMGH amd LTMMC Sion Mumbai India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7738904325 |
| Fax |
|
| Email |
rohinisekhar60@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rotary Club Aurangabad and Mahim Mumbai |
|
|
Primary Sponsor
|
| Name |
Rotary Club Aurangabad and Mahim Mumbai |
| Address |
Rotary Club Mahim Mumbai |
| Type of Sponsor |
Other [NGO] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mamta Manglani |
PCOE LTMGH LTMMC Sion Mumbai |
Pediatic Centre of Excellence Lokmanya Tilak Municipal General Hospital and Medical college sion mumbai 22
Mumbai
MAHARASHTRA |
982132071
mmanglani@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human Research SRS LTMGH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
HIV-infected children with moderate acute malnutrition between 6 months to 15 years, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
HIV infected MAM children with or wihtout ART who were given only nutritional counselling at first visit and during follow ups |
| Intervention |
Study group |
HIV-infected Moderate Acute Malnutrition children with or without ART received micronutrient fortified multigrain laddoo of 30 gms giving 146 Kcal and 5 gm proteins
Children were given one-third of calorie intake and half of protein requirement per day |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
6 months to 15 yr old children with HIV infection fulfilling Moderate Acute Malnutrition MAM criteria and under nutrition as per WHO definition yet not on ART
6 months to 15 yr old children wit HIV infection who are on ART and fulfill MAM criteria but have failed to gain weight in 2 consecutive visits 1 month apart |
|
| ExclusionCriteria |
| Details |
Patients already on vitamin mineral or any other nutritional supplementation |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Increase in weight height and improvement in immunity of study group with respect to control
Vitamin C levels increased in the study group with respect to control |
Enrollment October 2013 to August 2014
Follow up August 2014 to May 2015
Analysis May 2015 to August 2015 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vitamin C levels increased in the study group with respect to control |
Enrollment October 2013 to August 2014
Follow up August 2014 to May 2015
Analysis May 2015 to August 2015 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Title: Evaluation of the Effect of Nutritional Supplementation combined with counselling on the Nutritional Recovery in Immuno-Compromised Children
Principal Investigator: Dr. Mamta V. Manglani
Co-investigators: Dr. Alka Jadhav, Dr. Yashwant Gabhale, Dr. Mamatha Lala, Ms. Rohini Sekhar
Pediatric Centre of Excellence for HIV Care (PCoE), Department of Pediatrics, Lokmanya Tilak Municipal Medical College & General Hospital, Sion, Mumbai-22 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Background: In India, infected children constitute 4.4 percent of all people living with Human Immunodeficiency Virus, HIV. HIV and malnourishment creates a vicious cycle that eventually weakens the immune system further. It leads to poor nutrition, weight loss, muscle wasting, weakness and nutrient deficiency, impairing the immune system and reducing the ability to fight the virus. It also increases the risk of other infections due to an increased oxidative stress. Chronic oxidative state can affect immune systems fight against HIV, possibly by: increasing the production of HIV, weakening the immune system, making T cells destroy themselves, causing cells to make abnormal chemicals and making the body more sensitive to toxic effect of certain drugs. An increased damage wherein reactive oxygen intermediates called free radicals are generated may cause damage to cell membranes, proteins and nucleic acids, resulting in stores naturally occurring antioxidant reducing agents being depleted. Progressive oxidative stress and increased lipid peroxidation induced by the production of reactive oxygen species play a critical role in HIV replication and immunodeficiency. Such damage may be prevented or moderated by a normal antioxidant defence system that scavenges by reactive oxygen species. Antioxidants Vit. A, C, and E were found to be low in HIV infected children with respect to uninfected children due to an increase in utilization of antioxidant micronutrients-increased oxidative stress caused by free radicals. HIV-infected children are prone for malnutrition and are vulnerable for high mortality rate. Malondialdehyde, MDA, is an enzyme that is a marker of oxidative stress in the body. Aims and Objectives: To determine the effectiveness of nutritional supplementation on nutritional and biochemical parameters, assess the acceptability and palatability of multigrain mix supplementation; evaluate impact on CD4 counts with supplementation and to compare the levels of antioxidants in immune-compromised children before and after giving supplementation. Materials and Methods: Open prospective interventional case control study at the Pediatric Centre of Excellence for HIV Care at a tertiary care institution. Hundred patients, 50 in the study group consuming nutritional laddoos and receiving counselling, and 50 in the control group receiving only nutritional counselling, were enrolled and follow up was done for 6 months after laddoos were stopped for both the study and control group, so as to keep track of their change in weight, height and other clinical parameters. Special investigations like Vitamin C and MDA levels were monitored in 10 patients from the study group and control group each. Study Duration: October 2013 to August 2015. Inclusion Criteria: 6 months to 15-year old children with HIV infection, fulfilling Moderate Acute Malnutrition MAM criteria; under nutrition as per the WHO, yet not on ART and 6 months to 15-year old children with HIV infection who are on ART but having failure to gain weight on 2 consecutive visits. Exclusion Criteria: Patients already on vitamin/ mineral or any other nutritional supplementation. Results: Out of 100 patients in the study and control group, 37 were female and 63, male. Majority of the children belonged to the age group 12 to 15 years, followed by 9 to 12 years, 6 to 9 years, 3 to 6 years and 0 to 3 years. Thirty-seven patients from the study group were on ART and 13, not on ART whereas 42 patients from the control group were on ART and 8 not on ART. The mean weight gain and increase in height was significantly more in the study group, p less than 0.001, for a duration of 6 months for which they consumed nutritional laddoos, with respect to the control group. When the laddoos were stopped, the mean weight gain of the study group was insignificant with respect to the control group. However, the rate of weight gain was 8 times that of the control group, 8.21 gm per day and 1.05 gm per day respectively, at the end of 1 year. The CD4 count was seen to steadily increase in the study group whereas was seen to drop in the control group over a period of 1 year. The change in clinical staging was also more significant, p less than 0.001, in the study group compared to control group. Majority of the patients, 17 consumed only 20 to 40 percent of the laddoos required by them based on their weight and height, followed by 14 who consumed 80 to100 percent of the laddoos. The Vitamin C levels increased more significantly in the study group compared to the control group and the MDA levels dropped in the study group whereas continued to rise in the control group. Conclusion: This study provides a vital combination of protein and essential micronutrients and has proven to cause in increase in nutrition; weight, height and immunity of HIV-infected, MAM children. It runs parallel to the previous evidence found in literature and goes a long way in giving the HIV-infected children a better chance to lead a normal life and contribute to society.
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